Table 1.

Characteristics of allotransplant patients with BM EC < 0.1% or EC ≥ 0.1% pre-HSCT

Characteristics1EC < 0.1%, N = 301EC ≥ 0.1%, N = 38P*2EC < 0.1% + NAC, N = 352EC ≥ 0.1%, N = 39P†P‡
BM ECs pre-HSCT, median (range), % 0.04 (0.01-0.09) 0.2 (0.1-0.6) <.0001 0.05 (0.01-0.08) 0.2 (0.1-0.7) <.0001 .36 
Blood cell count at +2 mo post-HSCT, median (range)        
 WBC, ×109/L 3.2 (1.2-8.3) 5.1 (1.7-10.7) .04 3.75 (1.4-9.8) 3.6 (2.1-11.3) .59 .67 
 ANC, ×109/L 1.5 (0.6-5.1) 2.2 (0.7-9) .04 1.8 (0.7-8.8) 1.9 (0.8-7.4) .95 .18 
 Hb, g/L 90 (61-132) 99 (69-137) .13 96 (70-137) 97 (63-124) .67 .24 
 PLT, ×109/L 39 (13-142) 72 (28-262) .04 79 (45-175) 78 (42-196) .83 .005 
Age at HSCT, median (range), y 32 (16-52) 33 (18-58) .66 31 (16-54) 32 (18-55) .21 .42 
Sex, male/female 15/15 22/16 .63 17/18 17/22 .82 1.00 
Underlying disease, n   .81   1.00 .81 
 AML 16 22  17 20   
 ALL 14 16  18 19   
Status at HSCT, n   1.00   .81 1.00 
 Standard-risk 20 26  23 27   
 High-risk 10 12  12 12   
HCT-CI pre-HSCT score   .43   .91 .65 
 0-2 29 35  33 37   
 ≥3 1 3  2 2   
Source of stem cell   1.00   1.00 1.00 
 BM and PB, n 30 38  35 39   
Transplanted total nucleated cell dose, median (range), ×108/kg 7.9 (6.6-12.4) 8.1 (6.3-10.5) .85 8.2 (6.5-12.4) 8.2 (5.6-11.5) .13 .55 
Transplanted CD34+ cell dose, median (range), ×106/kg 2.8 (1.6-4.3) 3.1 (1.1-4.5) .38 3.0 (1.9-4.2) 2.8 (1.1-4.1) .55 .82 
Donor match, n   .60   1.00 .79 
 HLA ≤3 locus matched related donor 22 25  24 27   
 HLA >3 locus matched related donor 8 13  11 12   
Sex mismatch, n        
 Female to male 3 7 .49 5 3 .46 .72 
 Female to female 3 6 .72 4 6 1.00 1.00 
 Male to female 15 10 .08 14 16 .50 .33 
 Male to male 9 15 .45 12 14 1.00 .79 
ABO mismatch, n        
 No 16 27 .21 20 23 1.00 .81 
 Minor 9 4 .06 5 6 1.00 .14 
 Major 5 7 1.00 10 10 .80 .38 
Pre-HSCT cycles of chemotherapy, n (range) 4 (0-7) 4 (3-8) .11 4 (2-7) 4 (3-8) .08 .49 
Conditioning   1.00   1.00 1.00 
 BU/CY + ATG, n 30 38  35 39   
aGVHD post-HSCT, n 14 10 .12 14 16 1.00 .62 
Onset of aGVHD post-HSCT, median (range), d 24.5 (16-63) 23.5 (15-52) .34 25 (17-59) 25 (15-57) .28 .87 
aGVHD treatment, n   .94   .87 1.00 
 Steroid 10 7  10 11   
 Second- or third-line therapy 4 3  4 5   
TMA post-HSCT 0 1 1.00 0 1 1.00 1.00 
Onset of TMA post-HSCT, d  145   90   
CMV reactivation post-HSCT, n 24 21 .04 26 22 .14 .77 
Onset of CMV reactivation post-HSCT, median (range), d 35 (20-52) 36 (22-51) .56 35 (26-52) 36 (27-54) .49 .79 
CMV reactivation treated with ganciclovir, n 18 16 .22 20 16 .24 .82 
G-CSF administration post-HSCT, median (range), μg 5 012 (1 900-12 850) 3425 (1600-7750) <.0001 3700 (1600-7450) 3700 (1600-8750) .51 .008 
Transfusion of PLT post-HSCT, median (range), U 9.5 (1-36) 4 (0-10) <.0001 6 (0-18) 7 (0-20) .35 <.0001 
Transfusion of RBC post-HSCT, median (range), U 8 (0-20) 4 (0-12) <.0001 2 (0-22) 4 (0-18) .77 .04 
Characteristics1EC < 0.1%, N = 301EC ≥ 0.1%, N = 38P*2EC < 0.1% + NAC, N = 352EC ≥ 0.1%, N = 39P†P‡
BM ECs pre-HSCT, median (range), % 0.04 (0.01-0.09) 0.2 (0.1-0.6) <.0001 0.05 (0.01-0.08) 0.2 (0.1-0.7) <.0001 .36 
Blood cell count at +2 mo post-HSCT, median (range)        
 WBC, ×109/L 3.2 (1.2-8.3) 5.1 (1.7-10.7) .04 3.75 (1.4-9.8) 3.6 (2.1-11.3) .59 .67 
 ANC, ×109/L 1.5 (0.6-5.1) 2.2 (0.7-9) .04 1.8 (0.7-8.8) 1.9 (0.8-7.4) .95 .18 
 Hb, g/L 90 (61-132) 99 (69-137) .13 96 (70-137) 97 (63-124) .67 .24 
 PLT, ×109/L 39 (13-142) 72 (28-262) .04 79 (45-175) 78 (42-196) .83 .005 
Age at HSCT, median (range), y 32 (16-52) 33 (18-58) .66 31 (16-54) 32 (18-55) .21 .42 
Sex, male/female 15/15 22/16 .63 17/18 17/22 .82 1.00 
Underlying disease, n   .81   1.00 .81 
 AML 16 22  17 20   
 ALL 14 16  18 19   
Status at HSCT, n   1.00   .81 1.00 
 Standard-risk 20 26  23 27   
 High-risk 10 12  12 12   
HCT-CI pre-HSCT score   .43   .91 .65 
 0-2 29 35  33 37   
 ≥3 1 3  2 2   
Source of stem cell   1.00   1.00 1.00 
 BM and PB, n 30 38  35 39   
Transplanted total nucleated cell dose, median (range), ×108/kg 7.9 (6.6-12.4) 8.1 (6.3-10.5) .85 8.2 (6.5-12.4) 8.2 (5.6-11.5) .13 .55 
Transplanted CD34+ cell dose, median (range), ×106/kg 2.8 (1.6-4.3) 3.1 (1.1-4.5) .38 3.0 (1.9-4.2) 2.8 (1.1-4.1) .55 .82 
Donor match, n   .60   1.00 .79 
 HLA ≤3 locus matched related donor 22 25  24 27   
 HLA >3 locus matched related donor 8 13  11 12   
Sex mismatch, n        
 Female to male 3 7 .49 5 3 .46 .72 
 Female to female 3 6 .72 4 6 1.00 1.00 
 Male to female 15 10 .08 14 16 .50 .33 
 Male to male 9 15 .45 12 14 1.00 .79 
ABO mismatch, n        
 No 16 27 .21 20 23 1.00 .81 
 Minor 9 4 .06 5 6 1.00 .14 
 Major 5 7 1.00 10 10 .80 .38 
Pre-HSCT cycles of chemotherapy, n (range) 4 (0-7) 4 (3-8) .11 4 (2-7) 4 (3-8) .08 .49 
Conditioning   1.00   1.00 1.00 
 BU/CY + ATG, n 30 38  35 39   
aGVHD post-HSCT, n 14 10 .12 14 16 1.00 .62 
Onset of aGVHD post-HSCT, median (range), d 24.5 (16-63) 23.5 (15-52) .34 25 (17-59) 25 (15-57) .28 .87 
aGVHD treatment, n   .94   .87 1.00 
 Steroid 10 7  10 11   
 Second- or third-line therapy 4 3  4 5   
TMA post-HSCT 0 1 1.00 0 1 1.00 1.00 
Onset of TMA post-HSCT, d  145   90   
CMV reactivation post-HSCT, n 24 21 .04 26 22 .14 .77 
Onset of CMV reactivation post-HSCT, median (range), d 35 (20-52) 36 (22-51) .56 35 (26-52) 36 (27-54) .49 .79 
CMV reactivation treated with ganciclovir, n 18 16 .22 20 16 .24 .82 
G-CSF administration post-HSCT, median (range), μg 5 012 (1 900-12 850) 3425 (1600-7750) <.0001 3700 (1600-7450) 3700 (1600-8750) .51 .008 
Transfusion of PLT post-HSCT, median (range), U 9.5 (1-36) 4 (0-10) <.0001 6 (0-18) 7 (0-20) .35 <.0001 
Transfusion of RBC post-HSCT, median (range), U 8 (0-20) 4 (0-12) <.0001 2 (0-22) 4 (0-18) .77 .04 

The characteristics of allotransplant patients with BM EC < 0.1% or EC ≥ 0.1% pre-HSCT enrolled in the 2 clinical trials (NCT02978274 and NCT03236220) are shown in the table. The first trial included 2 groups of patients with 1EC < 0.1% (N = 30) and 1EC ≥ 0.1% (N = 38) enrolled from March 2016 to March 2017. The second trial included 2 groups of patients with 2EC < 0.1% + NAC (N = 35) and 2EC ≥ 0.1% (N = 39) enrolled from August 2017 to June 2018. The continuous variables were compared using the Mann-Whitney U test, and the differences in frequency between the 2 groups were compared using the χ2 test. The criterion for statistical significance was P < .05.

ALL, acute lymphocytic leukemia; AML, acute myelogenous leukemia; ATG, antithymocyte globulin; BU/CY, busulfan/cyclophosphamide; Hb, hemoglobin; PB, peripheral blood; PLT, platelet; RBC, red blood count; TMA, thrombotic microangiopathy; WBC, white blood cell.

*

The P values present the comparison between the 1EC < 0.1% (N = 30) and 1EC ≥ 0.1% (N = 38) groups.

†

The P values present the comparison between the 2EC < 0.1% + NAC (N = 35) and 2EC ≥ 0.1% (N = 39) groups.

‡

The P values present the comparison between the 1EC < 0.1% (N = 30) and 2EC < 0.1% + NAC (N = 35) groups.

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